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Until the FDA clearly allows specific peptides for use in dietary supplements, peptide-containing products are likely to remain a source of compliance and enforcement risk

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We stated in the proposed rule that we believe a 5-year period dating from the issuance of the Rebate Report allows for sufficient time to include AMP restatements in the MDRP while also placing a reasonable time limit on potential discretionary reconciliations, after which a manufacturer of a Part D rebatable drug will not receive additional Rebate Reports for the applicable period

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Although individual peptides have been investigated in various controlled studies, clinical data on the combined blend is limited, and further human trials are needed to establish efficacy and optimal dosing protocols